Healthy Diet for High Blood Pressure

(GoFresh Trial)

Not currently recruiting at 1 trial location

Overseen By Stephen P Juraschek, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Antihypertensives, SGLT2 inhibitors, Stimulants, others

Disqualifiers: Diabetes, Cardiovascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a special diet, guided by a dietitian, can help lower blood pressure in Black adults living in Boston's urban food deserts. Participants will receive home-delivered groceries that adhere to the DASH diet (Dietary Approaches to Stop Hypertension), recognized for its heart health benefits, for 12 weeks. Afterward, they will manage their diet using the knowledge gained. Eligible individuals are Black adults with slightly high blood pressure who live in specific Boston neighborhoods and can receive groceries at home or pick them up. As an unphased trial, this study provides participants the opportunity to contribute to valuable research on dietary impacts on heart health.

Will I have to stop taking my current medications?

If you are taking any medications that lower blood pressure or are intended for hypertension treatment, you must have stopped them at least 6 months before joining the trial. Additionally, if you are on certain other medications like potassium supplements, warfarin, or chronic oral corticosteroids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the DASH diet safely and effectively lowers blood pressure. This diet includes plenty of fruits, vegetables, and low-fat dairy products, which help reduce high blood pressure and cholesterol. Most people find the DASH diet easy to follow, and studies have reported no major side effects. It is considered a heart-healthy eating plan that can be maintained over the long term. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dietitian-Assisted DASH groceries approach because it offers a hands-on, personalized method to manage high blood pressure. Unlike typical treatments that might involve medication or general dietary advice, this approach involves a dietitian or nutritionist helping participants select groceries specifically tailored to the DASH diet, delivered straight to their homes. This method not only simplifies the process of eating healthily but also educates individuals on making better food choices on their own, potentially leading to long-term lifestyle changes. The combination of convenience, personalization, and education could make this a game-changer for people struggling with high blood pressure.

What evidence suggests that the Dietitian-Assisted DASH groceries could be effective for high blood pressure?

Research has shown that the DASH diet, which stands for Dietary Approaches to Stop Hypertension, can help lower blood pressure. People who follow this diet often see their top blood pressure number drop by about 11.8 points. In this trial, participants will either receive dietitian-assisted DASH groceries or engage in self-directed shopping. The DASH diet focuses on reducing cholesterol and unhealthy fats, which contribute to high blood pressure. It is widely recognized as one of the best diets for heart health and managing high blood pressure. Overall, research strongly supports the DASH diet as an effective way to reduce blood pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Stephen P Juraschek, MD, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for Black adults living in certain Boston areas without treated hypertension, with systolic blood pressure between 120-149 mm Hg and diastolic below 100 mm Hg. Participants must be able to receive and consume only provided groceries for 12 weeks, have kitchen facilities, Wi-Fi/cell service, and a device for grocery orders. Exclusions include severe health conditions like diabetes or recent cardiovascular events, significant weight changes recently, extreme diets or food insecurities.

Inclusion Criteria

Residence in communities identified as Boston area food deserts: Brighton, Chelsea, Dorchester, East Boston, Everett, Hyde Park, Jamaica Plain, Malden, Mattapan, Revere, Roslindale, Roxbury, or Winthrop

Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service

I can get groceries delivered or pick them up and will only eat these for 12 weeks.

Exclusion Criteria

Arm circumference >50cm

I have lost or gained more than 5% of my weight in the last 2 months.

I am not taking potassium supplements, warfarin, chronic steroids, or weight loss drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either dietitian-assisted DASH grocery delivery or a monthly stipend for self-directed shopping over a 12-week period

12 weeks

Weekly virtual or phone sessions for grocery orders

Observation

Participants are monitored for maintenance of dietary changes without the provision of groceries or stipend

9 months

In-person assessments at 3 months, phone visit at 9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

In-person assessments and qualitative interviews

What Are the Treatments Tested in This Trial?

Interventions

• Dietitian-Assisted DASH groceries
• Self-directed shopping

Trial Overview

The GoFresh trial is examining if home-delivered DASH-patterned groceries can lower blood pressure among Black adults in urban food deserts of Boston. It's a randomized study where some will get dietitian-assisted shopping while others will shop on their own.

How Is the Trial Designed?

Group I: Dietitian-Assisted DASH groceries Experimental Treatment 1 Intervention

Participants will order groceries sufficient to meet their caloric needs each week for 12 weeks with the assistance of a dietitian/nutrition interventionist. Groceries will be delivered to participants' homes or picked up at a convenient location. The dietitian/nutrition interventionist will provide brief educational content at the time of food delivery. Orders will be placed via phone or through virtual counseling sessions. During the remainder of the study (months 4-12), participants will be asked to apply what they learned without the provision of groceries.

Group II: Self-directed shopping (referent assignment) Active Control 1 Intervention

Participants will receive a monthly stipend over a 3 month period and some basic information about healthy eating. The stipend is not restricted to foods. During the remainder of the study (months 4-12), participants will be asked to continue their typical shopping without the provision of the monthly stipend.

Dietitian-Assisted DASH groceries is already approved in United States, Canada, European Union for the following indications:

Approved in United States as DASH Diet for:

• Hypertension
• High Blood Pressure

Approved in Canada as DASH Diet for:

• Hypertension
• High Blood Pressure

Approved in European Union as DASH Diet for:

• Hypertension
• High Blood Pressure

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

The DASH diet is effective in lowering blood pressure, but studies show that compliance with the diet is often suboptimal, especially in educational interventions compared to controlled feeding trials.

There is no consensus on the best method to assess compliance with the DASH diet, highlighting the need for more effective strategies to maintain adherence beyond just dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. Kwan, MW., Wong, MC., Wang, HH., et al.[2023]

A study of 2,831 adults in Iran found that adherence to the DASH diet is associated with lower levels of cardiovascular risk factors, including blood pressure, fasting blood sugar, triglycerides, and cholesterol.

Specifically, individuals in the highest quintile of DASH diet adherence had a 28% lower odds of hyperglycemia, suggesting that the DASH diet may be effective in reducing the risk of diabetes and other cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. Shoaibinobarian, N., Danehchin, L., Mozafarinia, M., et al.[2023]

The DASH diet, which emphasizes fruits, vegetables, nuts, and low-fat dairy while reducing saturated fats, led to an average reduction of 6 mmHg in systolic and 3 mmHg in diastolic blood pressure among patients, with even greater reductions in those with high blood pressure.

These significant blood pressure reductions were observed within just 2 weeks of starting the diet, indicating its potential effectiveness for managing hypertension in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. Kolasa, KM.[2020]

The DASH diet, which focuses on fruits, vegetables, low-fat dairy, whole grains, nuts, fish, and poultry while reducing fats and sugars, has been shown to effectively lower blood pressure, as demonstrated in the DASH clinical trial.

Healthcare practitioners, including dietitians, play a crucial role in helping individuals adopt the DASH diet by addressing ambivalence, enhancing motivation, and providing tailored dietary advice to fit personal lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Dietary Approaches to Stop Hypertension diet from research to practice: dietary and behavior change techniques. DASH Collaborative Research Group. Windhauser, MM., Ernst, DB., Karanja, NM., et al.[2019]

In a study of 144 overweight or obese adults with high blood pressure, those following the DASH diet alone or with weight management experienced significant reductions in blood pressure compared to those on a usual diet, highlighting the diet's efficacy as a nonpharmacologic treatment.

Greater adherence to the DASH diet was linked to larger decreases in blood pressure, and the study found that African Americans had lower adherence rates, suggesting the need for culturally tailored dietary strategies to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. Epstein, DE., Sherwood, A., Smith, PJ., et al.[2022]

In a study of 412 adults with pre- or stage 1 hypertension, combining a low sodium diet with the DASH diet resulted in significant reductions in systolic blood pressure (SBP), especially in individuals with higher baseline SBP levels (≥150 mm Hg), where reductions reached up to -20.8 mm Hg.

Reducing sodium intake alone also lowered SBP across all baseline levels, indicating that both dietary interventions are effective in managing blood pressure, with the most pronounced effects observed in those with higher initial blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. Juraschek, SP., Miller, ER., Weaver, CM., et al.[2022]

Following the DASH diet, which is rich in fiber, nutrients, and antioxidants, is linked to a lower prevalence of various cancers, suggesting it may have protective effects against cancer development.

While this review indicates a positive association between the DASH diet and cancer prevention, further longitudinal studies are needed to clarify the exact relationship due to the complex interactions among different foods and nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary approach to stop hypertension (DASH): diet components may be related to lower prevalence of different kinds of cancer: A review on the related documents. Onvani, S., Haghighatdoost, F., Azadbakht, L.[2020]

The DASH eating plan is beneficial for people with diabetes, as it not only helps control blood pressure but also improves insulin resistance and reduces high cholesterol levels.

This diet encourages a variety of healthy foods, making it suitable for the whole family and effective in managing weight and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DASH Eating Plan: An Eating Pattern for Diabetes Management. Campbell, AP.[2020]

The HF-DASH diet, which substitutes full-fat for low-fat dairy and reduces sugar intake, effectively lowers blood pressure similarly to the standard DASH diet while also reducing triglycerides and VLDL particle concentrations.

While both the DASH and HF-DASH diets lowered blood pressure, only the standard DASH diet significantly reduced LDL cholesterol and other harmful lipoproteins compared to a control diet, suggesting that the HF-DASH diet may be a safer alternative without compromising blood pressure benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Chiu, S., Bergeron, N., Williams, PT., et al.[2023]

Citations

1.

nhlbi.nih.gov

nhlbi.nih.gov/education/dash-eating-plan

DASH Eating Plan | NHLBI, NIH

It was named “Best Heart-Healthy Diet” and “Best Diet for High Blood Pressure” by U.S. News & World Report in 2025.

2.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK482514/

DASH Diet To Stop Hypertension - StatPearls - NCBI Bookshelf

The diet has been tested in several clinical trials and has been shown to lower cholesterol, saturated fats, and blood pressure.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10551663/

DASH Diet: A Review of Its Scientifically Proven Hypertension ...

During the intervention period, the DASH diet group experienced a significant decrease in systolic blood pressure by 11.8 ± 9.3 mmHg and a ...

4.

mayoclinic.org

mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/dash-diet/art-20048456

DASH diet: Healthy eating to lower your blood pressure

The DASH diet is a healthy-eating plan designed to help prevent or treat high blood pressure, also called hypertension.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2161831322000473

Dietary Approaches to Stop Hypertension (DASH) Diet and ...

The DASH diet compared with a control diet reduced SBP levels to a higher extent in trials with sodium intake >2400 mg/d than in trials with sodium intake ≤2400 ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/01.HYP.38.2.155

DASH (Dietary Approaches to Stop Hypertension) Diet Is ...

Our results indicate that the DASH diet, which is rich in fruits, vegetables, and low-fat dairy foods, is effective as first-line therapy in stage 1 ISH.

7.

heart.org

heart.org/en/health-topics/high-blood-pressure/changes-you-can-make-to-manage-high-blood-pressure/managing-blood-pressure-with-a-heart-healthy-diet

Managing Blood Pressure with a Heart-Healthy Diet

DASH means Dietary Approaches to Stop Hypertension. It focuses on healthy food sources and also limits: Red meat; Sodium (salt); Sweets, added ...